Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Tablet core
Hypromellose acetate succinate
Microcrystalline cellulose
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate

OPADRY Yellow 03F42210 (Tablet coating)
Hypromellose
Talc
Macrogol (8000)
Titanium dioxide (E171)
Iron oxide yellow (E172)

6.2    Incompatibilities
Not applicable.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
6.4    Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5    Nature and contents of container
40 mg film-coated tablets
Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets.
Each carton contains 112 film-coated tablets (4 wallets).

80 mg film-coated tablets
Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets.
Each carton contains 56 film-coated tablets (4 wallets).

6.6    Special precautions for disposal
Xtandi should not be handled by persons other than the patient or his caregivers. Based on its mechanism of action and embryo-fetal toxicity observed in mice, Xtandi may harm a developing fetus. Women who are or may become pregnant should not handle broken or damaged Xtandi tablets without protection, e.g. gloves. See section 5.3 Pre-clinical safety data. The film-coated tablets should not be chewed, cut or crushed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.     NAME OF MANUFACTURER
Astellas Pharma Europe B.V.,
Sylviusweg 62, 2333 BE Leiden, The Netherlands


8.     NAME OF REGISTRATION HOLDER

Astellas Pharma International B.V. 21 Ha’melacha Street, Rosh Ha’ayin, 4809157, Israel.